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Recruiting NCT07377682

Real-world Clinical Response to Trazodone in Italy, Poland, and Romania

— Observational Depression - Major Depressive Disorder Cognition Disorders in Old Age

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder, Cognition Disorders in Old Age. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Observational Prospective Study in Patients With Major Depressive Disorder and Mild Cognition Impairment Treated With Trazodone in a Real-world Setting (TRACOMDD)

Overview

TRACOMDD study is a study with the intention to describe the real-world use of trazodone and the clinical response in a sub-group of patients affected by Major Depressive Disorder and Mild Cognitive impairment, by collecting data from standard clinical practice in Italy, Poland, and Romania

Primary outcome measures

  • Depressive symptoms severity (MADRS) [Time frame: At 24 weeks from treatment]
Secondary outcome measures (8)
  • Depressive symptoms severity (MADRS) [Time frame: At 12 weeks from treatment]
  • Clinical response (CGI) [Time frame: At 24 weeks from treatment]
  • Cognitive functioning (MoCA) [Time frame: At 24 weeks from treatment]
  • Sleep quality (SQS) [Time frame: At 24 weeks from treatment]
  • To describe the response in terms of quality of life (EQ-5D-5L) [Time frame: At 24 weeks from treatment]
  • Absolute and relative frequency of patients [Time frame: Over 24 weeks]
  • Serious adverse events of prolonged release trazodone [Time frame: Over 24 weeks]
  • Drug related adverse events of prolonged release trazodone [Time frame: Over 24 weeks]

Eligibility criteria

Inclusion criteria

  • Patients aged 55 or older.
  • Patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD diagnosis.
  • Patients experiencing a current major depressive episode of at least moderate severity, defined by a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥20 at enrolment.
  • Patients with a diagnosis of MCI (also referred to as "mild neurocognitive disorder") according to the DSM-5 criteria.
  • Patients who start treatment with trazodone hydrochloride (prolonged release) with starting dosage according to SmPC at enrolment visit (or at latest within one week).
  • Patients legally capable of giving their written consent to participate in the study (including personal data processing) and willing to comply with all study procedures as per clinical judgement.

Exclusion criteria

  • Patients who meet any of the contraindications to the administration of trazodone according to the approved local SmPC.
  • Known hypersensitivity or allergy to the active ingredient and/or to any component of the study medication.
  • Concomitant treatment with other antidepressant drugs, mood stabilizers, antipsychotics, and/or proved resistance to trazodone monotherapy.
  • Patients with current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, severe personality disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition.
  • Patients with previous or current history of any neurological condition that, in the opinion of the Investigator, might compromise participation in the study.
  • Patients participating in any interventional study in the 30 days prior to the enrolment visit.
  • Patients with ongoing pregnancy or breast-feeding at enrolment visit.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Poradnia Medycyna Miłorząb: pl. Pokoju 3/4, 90-227 Łódź. Poland — Lodz

Identifiers

NCT: NCT07377682 · 039(Z)MD24063

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗